Our Core Services
Services
eCTD Publishing
Seamlessly manage your regulatory submissions with precision and compliance.
We specialize in preparing and managing electronic Common Technical Document (eCTD) submissions to meet the stringent requirements of regulatory authorities worldwide. Our eCTD publishing services include:
- Document Formatting and Preparation: Ensuring all documents adhere to the technical requirements of eCTD standards.
- Validation and Quality Checks: Conducting rigorous checks to ensure submissions pass technical validation without errors.
- Lifecycle Management: Managing updates, amendments, and submissions across the entire product lifecycle.
- Global Compliance: Adhering to the specific regulatory requirements of various markets, including the FDA, EMA, and more.
- Seamless Integration with Submission Management: Collaborating across teams to ensure timely and compliant submissions.
Submission Management
Streamlining the submission process to ensure timely approvals.
Our submission management services focus on overseeing and coordinating the preparation, validation, and submission of regulatory dossiers. Key features include:
- Dossier Assembly: Organizing and compiling dossiers in accordance with regulatory guidelines.
- Timeline Coordination: Ensuring submissions meet deadlines without compromising on quality.
- Stakeholder Communication: Acting as the central point of contact between your teams and regulatory authorities.
- End-to-End Support: From initial submission planning to post-submission follow-ups.
- Lifecycle and Change Management: Addressing changes during the submission process or post-approval.
Submission Writing
Crafting clear and compliant content for all regulatory sections.
Our expert submission writers provide high-quality, precise, and regulatory-compliant content for all sections of your submissions, spanning Module 1 to Module 5. Services include:
Our submission writing ensures accuracy, clarity, and adherence to the latest regulatory requirements across all modules.
- Module 1 (Administrative Information and Prescribing Information): Writing regional-specific administrative content, including cover letters, application forms, and labeling documents.
- Module 2 (Common Technical Document Summaries): Crafting high-level summaries and overviews of non-clinical and clinical data.
- Module 3 (Quality): Preparing comprehensive details about the drug substance and drug product, including manufacturing, control, and stability data.
- Module 4 (Non-Clinical Study Reports): Writing summaries and detailed reports on pharmacology, toxicology, and other non-clinical studies.
- Module 5 (Clinical Study Reports): Developing comprehensive clinical reports, data summaries, and patient narratives for regulatory review.
SPL and Labeling
Accurate and compliant labeling for seamless regulatory approvals.
Our Structured Product Labeling (SPL) and labeling services ensure that your product information is accurate, compliant, and consistent across markets. Services include:
- SPL Creation and Submission: Developing and submitting SPL documents in compliance with FDA and other global regulations.
- Label Design and Updates: Creating and revising labels to reflect accurate product information.
- Global Labeling Alignment: Managing consistency across multiple regions while meeting specific local requirements.
- Regulatory Compliance: Ensuring labeling meets the latest standards and expectations of regulatory bodies.
Registrations
Efficient product registrations for seamless market entry.
We provide comprehensive support to manage your product registrations across global markets, ensuring a smooth regulatory journey. Our FDA-related registration services include:
Our team ensures that your product registrations are handled accurately, efficiently, and in full compliance with FDA guidelines, enabling timely market entry and approval.
- Establishment Registration: Assisting with the registration of manufacturing, processing, and packaging establishments to comply with FDA requirements.
- Self-Identification: Supporting self-identification submissions as required under the Generic Drug User Fee Amendments (GDUFA) to maintain compliance for ANDA-related activities.
- Labeler Code Request: Managing the process for obtaining or updating Labeler Codes in the FDA’s National Drug Code (NDC) Directory.
- Drug Master File (DMF) Submission and Request: Preparing and submitting DMFs to ensure secure and confidential sharing of critical product information with the FDA.
- Market-Specific Compliance: Adhering to unique regulatory requirements in target regions.
Regulatory Strategy Development
Crafting pathways for compliance and success.
Our regulatory strategy services are tailored to simplify the complexities of global compliance while aligning with your business goals. Services include:
- Gap Analysis: Identifying and addressing compliance gaps to mitigate risks.
- Regulatory Roadmaps: Developing comprehensive strategies to navigate requirements in specific markets.
- Lifecycle Management: Supporting your product through every phase, from development to post-market compliance.
- Cross-Functional Alignment: Coordinating with R&D, clinical, and commercial teams to ensure unified strategies.
Dossier Management
Comprehensive control and organization for regulatory dossiers.
We ensure that your regulatory dossiers are well-managed, up-to-date, and compliant with global requirements. Services include:
- Dossier Compilation: Preparing complete, accurate, and structured dossiers for submission.
- Centralized Document Control: Ensuring all documents are stored, version-controlled, and easily accessible.
- Regulatory Authority Queries: Managing responses to questions or deficiencies raised by regulators.
- Dossier Updates: Keeping dossiers current with regulatory changes and product updates.
Lifecycle Management
Ensuring your product remains compliant throughout its lifecycle.
Our lifecycle management services ensure your product maintains regulatory compliance from development to post-market. Services include:
- Post-Approval Submissions: Managing variations, renewals, and amendments to regulatory dossiers.
- Change Control: Addressing changes in manufacturing, labeling, or product specifications.
- Risk Mitigation: Identifying and resolving potential compliance issues early.
- Market Expansion Support: Assisting in registering your product in new regions.
Our Ad-Hoc Services
USAN and INN Applications
Secure Unique Names for Your Molecules
- Assistance with applying for United States Adopted Names (USAN) and International Nonproprietary Names (INN).
- Comprehensive documentation support to meet the stringent requirements of the USAN Council and WHO INN Program.
- Ensuring the unique identification of your active substances for regulatory compliance and global recognition.
Secure Email Connections for Regulatory Correspondence
Streamlined and Confidential Communication
- Setting up and managing secure email systems to ensure safe correspondence with regulatory agencies like FDA, EMA, and CDSCO.
- Facilitating encrypted communications to protect sensitive data and maintain confidentiality.
- Managing regulatory accounts and connections, including FDA ESG (Electronic Submission Gateway) and EU CESP (Centralized Submission Portal).
CT.Gov Registration and Updates
Stay Compliant with Clinical Trial Regulations
- Expertise in registering clinical trials on ClinicalTrials.gov, ensuring compliance with global standards.
- Management of study updates, amendments, and results submissions as per FDA and ICMJE (International Committee of Medical Journal Editors) requirements.
- Guidance for accurate representation of trial information to enhance transparency and visibility.
FSSAI Registrations and Compliance
Simplifying Food Safety Approvals for Pharma Products
- Assistance with obtaining Food Safety and Standards Authority of India (FSSAI) licenses and registrations for nutraceuticals, food supplements, and related products.
- End-to-end support for compliance with India’s food safety regulations, including label verification and product approvals.
- Streamlining processes for faster market entry in the Indian market.
Patent and Trademark Services
Protect Your Innovations
- Comprehensive support for filing patents and trademarks for your pharmaceutical products, processes, and brands.
- Assistance with drafting, reviewing, and submitting patent applications to ensure global intellectual property protection.
- Expertise in navigating patent laws in India, the USA, and Europe to secure your innovation’s exclusivity.